Percutaneous Transluminal Angioplasty (PTA) Cath
510(k) K902317
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902317 | Date3 Dec 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Percutaneous Transluminal Angioplasty (PTA) Cath is a catheter used for angioplasty procedures to restore blood flow in clogged arteries due to peripheral artery disease. It is a type of catheter used in minimally invasive endovascular procedures. The device is used to perform percutaneous transluminal angioplasty, which involves inserting a catheter into an artery to clear blockages.
The PTA Cath is supplied as a single-use device and is intended for use in cardiovascular procedures. It is regulated under the product code LIT and has a regulation number of 870.1250. The device has been authorized by the FDA under the 510K clearance process, with a decision description of Substantially Equivalent. The catheter is available in various sizes, although specific sizes are not listed in the provided data.
Other devices from Mallinckrodt Medical
Questions
AI-generated answers, 24 Sep 2026
What is the Percutaneous Transluminal Angioplasty (PTA) Catheter used for?
The PTA Catheter is used in angioplasty procedures to restore blood flow in clogged arteries caused by peripheral artery disease. It is designed for minimally invasive endovascular procedures to clear blockages in arteries.
Is the PTA Catheter single-use or reusable?
The PTA Catheter is supplied as a single-use device and is intended for use in cardiovascular procedures. It should not be reused on multiple patients due to infection risks and device integrity concerns.
What sizes are available for the PTA Catheter?
The PTA Catheter is available in various sizes to accommodate different clinical needs and patient anatomies. However, specific size dimensions are not provided in the available product information.
What is the regulatory status of the PTA Catheter?
The PTA Catheter has been authorized by the FDA under the 510K clearance process with a decision description of Substantially Equivalent. It is regulated under product code LIT with regulation number 870.1250.